Amplatzer™ Amulet™ Left Atrial Appendage Occluder

FDA Premarket Approval P200049 S004

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceAmplatzer™ Amulet™ Left Atrial Appendage Occluder
Generic NameSystem, Appendage Closure, Left Atrial
ApplicantAbbott Medical5050 Nathan Lane Northplymouth, MN 55442 PMA NumberP200049 Supplement NumberS004 Date Received06/16/2022 Decision Date07/28/2022 Product Code NGV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-06-16
Decision Date2022-07-28
PMAP200049
SupplementS004
Product CodeNGV 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressAbbott Medical
5050 Nathan Lane North
plymouth, MN 55442 PMA NumberP200049 Supplement NumberS004 Date Received06/16/2022 Decision Date07/28/2022 Product Code NGV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
the Addition Of Alternate Laser Cutting And Welding Systems Used In The Manufacturing Of The Amplatzer Amulet Left Atrial Appendage Occluder

Supplemental Filings

Supplement NumberDateSupplement Type
P200049Original Filing
S004 2022-06-16 30-day Notice
S003 2021-11-05 30-day Notice
S002
S001 2021-08-24 30-day Notice

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